EP2866592A1 - Method for producing a film formulation for an edible film, and the use thereof - Google Patents

Method for producing a film formulation for an edible film, and the use thereof

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Publication number
EP2866592A1
EP2866592A1 EP12733056.1A EP12733056A EP2866592A1 EP 2866592 A1 EP2866592 A1 EP 2866592A1 EP 12733056 A EP12733056 A EP 12733056A EP 2866592 A1 EP2866592 A1 EP 2866592A1
Authority
EP
European Patent Office
Prior art keywords
solution
weight
film
edible film
edible
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP12733056.1A
Other languages
German (de)
French (fr)
Other versions
EP2866592B1 (en
Inventor
Laura ZIMMERMANN
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Optimags Dr Zimmermann GmbH
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Optimags Dr Zimmermann GmbH
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Publication date
Application filed by Optimags Dr Zimmermann GmbH filed Critical Optimags Dr Zimmermann GmbH
Priority to PL12733056T priority Critical patent/PL2866592T3/en
Publication of EP2866592A1 publication Critical patent/EP2866592A1/en
Application granted granted Critical
Publication of EP2866592B1 publication Critical patent/EP2866592B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/10—Foods or foodstuffs containing additives; Preparation or treatment thereof containing emulsifiers
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L35/00—Food or foodstuffs not provided for in groups A23L5/00 – A23L33/00; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

Definitions

  • the present invention relates to a process for producing a film formulation for an edible film and an edible film, and to the use thereof.
  • edible films are used to provide food additives in exact dosages to food processing companies, such as food colors, spices, enzymes, and ingredients for cold mix drinks. These food additives are dosed directly onto the edible film and, together with this, added to the food.
  • the edible film dissolves completely in water within usually one minute.
  • edible films are also used recently to administer bioactive substances, in particular Med ikamente in an exact dosage orally.
  • bioactive substances in particular Med ikamente in an exact dosage orally.
  • the med izin ische drug is applied to an edible film and optionally covered with a second film.
  • the active ingredient is taken up by placing the edible foil provided with the bioactive substance in the mouth and remaining there until the edible foil has dissolved.
  • Medications that are orally administered have traditionally been administered as tablets or capsules.
  • the active ingredients In order to develop the desired medical effect, the active ingredients must always be dosed in a high degree of accuracy, with many active substances only being used in very small amounts
  • Microgram may be supplied.
  • tablets and capsules must have a certain minimum size or minimum mass in order to be manageable for the persons to be treated. Accordingly, the active pharmaceutical ingredients for the production of tablets or capsules with fillers and binders are added in considerable quantities. These substances must be compatible with both the organism and the medicinal agent so that their preparation and delivery already represents a significant cost factor in the manufacture of the finished medicament. Furthermore, it is necessary to completely mix the medicinal agent and the additives or binders, which makes expensive machines necessary. Finally, for successful therapy, it is often desirable to administer smaller units of active ingredient orally than the amount of active ingredient contained in a tablet or capsule. The sharing of tablets is hardly possible in the desired and possibly even required accuracy.
  • DE 102010 009071 A1 also discloses an edible film and a method for the production thereof.
  • oily-based ingredients for example, essential oils that positively affect the taste of the edible film.
  • essential oils that positively affect the taste of the edible film.
  • Edible films made by a process of the present type are typically machined, tested, cut into pieces and packaged.
  • the film material must have a corresponding mechanical strength.
  • care must be taken that the edible film contains no air pockets. So far, the production of a film formulation for an edible film therefore had to be carried out at least partially under vacuum, which naturally increased the effort for the production of the film formulation.
  • the object of the present invention is achieved by a process for producing a film formulation for an edible film comprising the following steps: a) Preparation of a solution A by stirring at a temperature in the range between 20 ° to 100 ° C, wherein the solution A Starch, polyethylene glycol, glycerol, polyvinyl alcohol, at least one defoamer, sugar, at least one oily component, at least one emulsifier and water as solvent, b) homogenizing and homogenizing the temperature of the solution obtained in step (a) to a temperature of at least 70 ° C, preferably to about 80 ° C to
  • oils such as peppermint oil
  • they serve as flavors in the edible film, for example.
  • oily pharmaceutical agents it is also possible to incorporate oily pharmaceutical agents in an edible film.
  • the defoamer prevents bubble formation, so that in many cases the process according to the invention can be carried out with good results under normal ambient pressure.
  • the preparation of solution A comprises the following steps: a) preparation of a solution B stirring at a temperature in the range between 20 ° and 100 ° C., solution B being polyethylene glycol, Glycerol, polyvinyl alcohol, at least one defoamer, sugar, at least one oily component, at least one Emu lgator and water as a solvent, ß) Preparation of a solution C by dissolving starch in water at Griffintemperatu r, ⁇ ) Einrüh ren of the solution B in solution C.
  • the preparation of solution A or the preparation of solution B comprises the following steps: i) dissolving polyethylene glycol and glycerol in boiling water, ii) homogenizing the solution obtained in step (i),
  • step (viii) adding the mixture of substances obtained in step (vii) to the solution obtained in steps (i) to (vi).
  • Such a process makes it possible to produce edible films which have a dry and uniform film surface even after long storage.
  • the homogenization is preferably carried out in a stirred tank at 10,000 to 20,000 revolutions per minute, in particular at 16,000 revolutions per minute, whereby the quality, in particular the uniformity of the film surface, of the edible films which are produced from the film formulation is improved.
  • step (vii) is performed at about room temperature so as not to affect the quality of the oily component used.
  • the film formulation becomes an edible film
  • a suitable emulsion stabilizer is hydroxypropylmethylcellulose (HPMC E3).
  • HPMC E3 hydroxypropylmethylcellulose
  • defoamers and as emulsifier modified polydimethoxysilanes are used.
  • an edible film wherein the edible film of a film formulation, which was prepared according to the manufacturing method according to the invention, is prepared, that contains at least one oily component.
  • an edible film has a uniform film surface and is dry because the oily components are prevented from leaking or agglomerating in the edible film by the use of an emulsifier and a defoamer.
  • an edible film contains no or very little air pockets, which increases the flexibility of the film and its brittleness is reduced. Last but not least, this also allows even more accurate dosing of ingredients of the edible film.
  • the edible film according to the invention is expediently produced in a thickness of approximately 60 m to 100 m.
  • the object of the present invention is achieved by a use of the edible film according to the invention for oral administration of bioactive substances.
  • the edible film is used as a carrier medium for the oral administration of bioactive substances and more preferably of medicaments.
  • the object of the present invention is achieved by using the edible film according to the invention for dosing food additives.
  • raw materials for producing a film formulation for an edible film for example, the following raw materials are used:
  • the water content of the edible film according to the invention depends on the conditions of drying and may vary.
  • a production process of a film formulation for an edible film in which one or more oily components are bound and air bubbles produced in the manufacturing process are reduced may be as follows: a) 50% of the total amount of water is heated until the boiling temperature is reached is.
  • This mixture is added as a defoamer, a modified polydimethylsiloxane.
  • step (e) In parallel, the required amount of the oily component (or a mixture of several oily components) is mixed with the emulsifier in a separate container and added to the solution of step (e). f) In a further step is parallel in a separate container the
  • step (e) The solution obtained in step (e) is stirred into the solution from step (d). While maintaining the speed of step (b) for the homogenizer, the solution is heated to a temperature of 80 ° C. Upon reaching the desired temperature, the starch is completely bound. i) Finally, the mixture is cooled down to 50 ° C.
  • the film formulation is cooled and processed into an edible film.
  • it may contain, in addition to the above-mentioned substances, pharmaceutical substances and / or auxiliary substances such as flavoring agents and / or (food) dyes.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to a method for producing a film formulation for an edible film, having the following steps: (a) producing a solution A by means of a stirring process at a temperature ranging from 20 °C to 100 °C, wherein the solution A contains starch, polyethylene glycol, glycerin, polyvinyl alcohol, at least one defoamer, sugar, at least one oily component, at least one emulsifier, and water as a solvent, (b) homogenizing the solution obtained in step (a) and bringing the temperature of same up to a temperature of approximately 80 °C, and (c) cooling the solution obtained in step (b). The invention further relates to an edible film and to the use thereof.

Description

Verfahren zu r Herstellung einer Folienformu lierung für eine essbare Folie und deren Verwendung  Process for the preparation of a film formulation for an edible film and its use
Besch reibung Description
Die vorliegende Erfindung betrifft ein Verfahren zur Herstellung einer Folienformulierung für eine essbare Folie und eine essbare Folie sowie deren Verwendung. The present invention relates to a process for producing a film formulation for an edible film and an edible film, and to the use thereof.
Essbare Folien werden beispielsweise verwendet, um Lebensmittelzusatzstoffe in exakter Dosierung für Lebensmittel verarbeitende Betriebe bereitzustellen , beispielsweise Lebensmittelfarbstoffe, Gewürze, Enzyme sowie Zutaten für Kaltmixgetränke. Diese Lebensmittelzusatzstoffe werden d irekt auf d ie essbare Folie dosiert und mit d ieser zusammen den Lebensmitteln zugegeben . Die essbare Folie löst sich dabei innerhalb von normalerweise einer Minute in Wasser vollständ ig auf. For example, edible films are used to provide food additives in exact dosages to food processing companies, such as food colors, spices, enzymes, and ingredients for cold mix drinks. These food additives are dosed directly onto the edible film and, together with this, added to the food. The edible film dissolves completely in water within usually one minute.
Neben dem eben genannten Einsatzzweck werden essbare Folien in jüngster Zeit auch dazu verwendet, bioaktive Substanzen , insbesondere Med ikamente in exakter Dosierung oral zu verabreichen . Dies ist auch das bevorzugte Anwendungsgebiet der vorliegenden Erfindung. Hierzu wird der med izin ische Wirkstoff auf eine essbare Folie aufgebracht und gegebenenfalls mit einer zweiten Folie abgedeckt. Der Wirkstoff wird aufgenommen , indem die mit der bioaktiven Substanz versehene essbare Folie in den Mund genommen wird und dort verbleibt, bis sich d ie essbare Folie aufgelöst hat. In addition to the purpose just mentioned edible films are also used recently to administer bioactive substances, in particular Med ikamente in an exact dosage orally. This is also the preferred field of application of the present invention. For this purpose, the med izin ische drug is applied to an edible film and optionally covered with a second film. The active ingredient is taken up by placing the edible foil provided with the bioactive substance in the mouth and remaining there until the edible foil has dissolved.
Medikamente, d ie oral zu verabreichen sind , werden bislang in der Regel als Tabletten oder Kapseln verabreicht. U m d ie erwünschte med izin ische Wirkung zu entfalten , müssen d ie Wirkstoffe allerd ings in seh r hoher Genau igkeit dosiert werden , wobei viele Wirkstoffe nur in geringsten Mengen von wen igen Medications that are orally administered have traditionally been administered as tablets or capsules. In order to develop the desired medical effect, the active ingredients must always be dosed in a high degree of accuracy, with many active substances only being used in very small amounts
Mikrogramm zugeführt werden dü rfen . Andererseits müssen Tabletten und Kapseln jedoch eine gewisse Mindestgröße bzw. Mindestmasse aufweisen, um für die zu behandelnden Personen handhabbar zu sein. Dementsprechend werden die medizinischen Wirkstoffe zur Herstellung von Tabletten oder Kapseln mit Füllstoffen und Bindemitteln in beträchtlicher Menge versetzt. Diese Stoffe müssen sowohl für den Organismus als auch für den medizinischen Wirkstoff verträglich sein, so dass deren Herstellung und Bereitstellung bereits einen beträchtlichen Kostenfaktor bei der Herstellung des fertigen Medikaments darstellt. Des Weiteren ist es notwendig, den medizinischen Wirkstoff und die Zuschlagsstoffe bzw. Bindemittel vollständig zu durchmischen, was aufwendige Maschinen notwendig macht. Schließlich ist es für eine erfolgreiche Therapie oft wünschenswert, kleinere Wirkstoffeinheiten oral zu verabreichen, als diejenige Wirkstoffmenge, die in einer Tablette oder Kapsel enthalten ist. Das Teilen von Tabletten ist jedoch kaum in der gewünschten und gegebenenfalls sogar erforderlichen Genauigkeit möglich. Microgram may be supplied. On the other hand, however, tablets and capsules must have a certain minimum size or minimum mass in order to be manageable for the persons to be treated. Accordingly, the active pharmaceutical ingredients for the production of tablets or capsules with fillers and binders are added in considerable quantities. These substances must be compatible with both the organism and the medicinal agent so that their preparation and delivery already represents a significant cost factor in the manufacture of the finished medicament. Furthermore, it is necessary to completely mix the medicinal agent and the additives or binders, which makes expensive machines necessary. Finally, for successful therapy, it is often desirable to administer smaller units of active ingredient orally than the amount of active ingredient contained in a tablet or capsule. The sharing of tablets is hardly possible in the desired and possibly even required accuracy.
Vor diesem Hintergrund gibt es seit einiger Zeit auch essbare Folien, die als Trägermaterial für den medizinischen Wirkstoff dienen können. Die Dosierung des medizinischen Wirkstoffs ist dabei in geringsten Mengen und in hoher Genauigkeit möglich, da er feinst verteilt auf die Oberfläche der essbaren Folie aufgebracht werden kann. Die Flächeneinheiten der essbaren Folie entsprechen dann sehr exakt einer spezifischen Dosierung des medizinischen Wirkstoffs. Beispiele für solche essbaren Folien sind beispielsweise in der US Against this background, there have been edible films for some time, which can serve as a carrier material for the medical active substance. The dosage of the medicinal agent is possible in very small quantities and with high accuracy, since it can be applied to the surface of the edible film in a very finely distributed manner. The surface units of the edible film then correspond very exactly to a specific dosage of the medicinal active substance. Examples of such edible films are, for example, in the US
2004/0136923A1 und in der EP 1 306071 B1 zu finden. Auch in der DE 102010 009071 A1 ist eine essbare Folie und ein Verfahren zu deren Herstellung offenbart. 2004 / 0136923A1 and in EP 1 306071 B1. DE 102010 009071 A1 also discloses an edible film and a method for the production thereof.
Für unterschiedliche Anwendungszwecke, insbesondere zur oralen Verabreichung von Medikamenten, ist es wünschenswert, in die essbaren Folien Inhaltsstoffe auf öliger Basis einzubringen, beispielsweise ätherische Öle, die den Geschmack der essbaren Folie positiv beeinflussen. Soweit essbare Folie mit Inhaltsstoffen auf öliger Basis länger gelagert werden, ergibt sich bei essbaren Folien nach dem Stand der Technik allerdings das Problem, dass diese Inhaltsstoffe nach einiger Zeit der Lagerung wieder aus der essbaren Folie austreten oder agglomerieren. Hierdurch fühlt sich die Folienoberfläche dann nicht mehr trocken an, was von den Anwendern als minderwertig empfunden werden könnte. Des Weiteren könnten Ölagglomerate die exakte Gleichverteilung des Gewichts der essbaren Folie über deren Fläche beeinträchtigen, was insbesondere bei medizinischen Anwendungen Probleme bereiten kann. For various applications, especially for oral administration of medicaments, it is desirable to incorporate oily-based ingredients into the edible films, for example, essential oils that positively affect the taste of the edible film. As far as edible film with ingredients on an oily basis are stored longer, resulting in edible films according to the prior art, however, the problem that these ingredients emerge after some time storage again from the edible film or agglomerate. As a result, the film surface then no longer feels dry, which could be perceived by the users as inferior. Furthermore, oil agglomerates could affect the exact uniform distribution of the weight of the edible film over the surface, which can cause problems especially in medical applications.
Essbare Folien, die nach einem Verfahren der vorliegenden Art hergestellt werden, werden in der Regel maschinell verarbeitet, geprüft, in Stücke geschnitten und verpackt. Hierfür muss das Folienmaterial eine entsprechende mechanische Belastbarkeit aufweisen. In diesem Zusammenhang muss darauf geachtet werden, dass die essbare Folie keine Lufteinschlüsse enthält. Bislang musste das Herstellen einer Folienformulierung für eine essbare Folie daher zumindest teilweise unter Vakuum erfolgen, was naturgemäß den Aufwand für die Herstellung der Folienformulierung erhöhte. Edible films made by a process of the present type are typically machined, tested, cut into pieces and packaged. For this purpose, the film material must have a corresponding mechanical strength. In this context, care must be taken that the edible film contains no air pockets. So far, the production of a film formulation for an edible film therefore had to be carried out at least partially under vacuum, which naturally increased the effort for the production of the film formulation.
Aufgabe der vorliegenden Erfindung ist es daher, ein Herstellungsverfahren für essbare Folien bereitzustellen, in die ölige Komponenten stabil eingelagert werden können und die trotz unaufwendiger Herstellung eine hohe mechanische Stabilität aufweisen. It is therefore an object of the present invention to provide a production process for edible films in which oily components can be stored in a stable manner and which, despite the uncomplicated production, have a high mechanical stability.
Die Aufgabe der vorliegenden Erfindung wird durch ein Verfahren zur Herstellung einer Folienformulierung für eine essbare Folie gelöst, das die folgenden Schritte umfasst: a) Herstellung einer Lösung A durch Rühren bei einer Temperatur im Bereich zwischen 20 ° bis 100 °C, wobei die Lösung A Stärke, Polyethylenglykol, Glycerin, Polyvinylalkohol, mindestens einen Entschäumer, Zucker, mindestens eine ölige Komponente, mindestens einen Emulgator und Wasser als Lösungsmittel enthält, b) Homogen isieren und Temperieren der in Schritt (a) erhaltenen Lösung auf eine Temperatu r von mindestens 70 °C, vorzugsweise auf ca. 80 °C bisThe object of the present invention is achieved by a process for producing a film formulation for an edible film comprising the following steps: a) Preparation of a solution A by stirring at a temperature in the range between 20 ° to 100 ° C, wherein the solution A Starch, polyethylene glycol, glycerol, polyvinyl alcohol, at least one defoamer, sugar, at least one oily component, at least one emulsifier and water as solvent, b) homogenizing and homogenizing the temperature of the solution obtained in step (a) to a temperature of at least 70 ° C, preferably to about 80 ° C to
85 °C, c) Herunterkühlen der in Sch ritt (b) erhaltenen Lösung . 85 ° C, c) cooling down the solution obtained in step (b).
Als ölige Komponente können ätherische Öle, wie beispielsweise Pfefferminzöl, eingesetzt werden , d ie beispielsweise als Geschmackstoffe in der essbaren Folie dienen . Mit der vorliegenden Erfindung ist es jedoch auch möglich , ölige pharmazeutische Wirkstoffe in einer essbaren Folie einzubinden . As the oily component, essential oils such as peppermint oil can be used, ie, they serve as flavors in the edible film, for example. With the present invention, however, it is also possible to incorporate oily pharmaceutical agents in an edible film.
Durch d ie Verwendung eines Emu lgators, der d ie ölige Komponente dispergiert, wird langfristig verh indert, dass es zu einem Austritt der öligen Komponente aus der essbaren Folie oder zu einer Agglomerierung kommt. The use of an emulsifier which disperses the oily component prevents in the long term that the oily component leaves the edible film or agglomerates.
Zudem verhindert der Entschäu mer eine Bläschenbildung, so dass das erfindungsgemäße Verfahren in vielen Fällen mit guten Ergebn issen unter normalem U mgebungsdruck du rchgeführt werden kann . In addition, the defoamer prevents bubble formation, so that in many cases the process according to the invention can be carried out with good results under normal ambient pressure.
I n einer bevorzugten Ausführungsform der Erfindung umfasst d ie Herstellung der Lösung A d ie folgenden Sch ritte: a) Herstellung einer Lösung B du rch Rüh ren bei einer Temperatur im Bereich zwischen 20 ° bis 1 00 °C, wobei die Lösung B Polyethylenglykol, Glycerin , Polyvinylalkohol, mindestens einen Entschäumer, Zucker, mindestens eine ölige Komponente, mindestens einen Emu lgator und Wasser als Lösungsmittel enthält, ß) Herstellung einer Lösung C durch Lösen von Stärke in Wasser bei Raumtemperatu r, γ) Einrüh ren der Lösung B in Lösung C. In einer weiter bevorzugten Ausführungsform der Erfindung umfasst die Herstellung der Lösung A oder die Herstellung der Lösung B die folgenden Schritte: i) Auflösen von Polyethylenglykol und Glycerin in siedendem Wasser, ii) Homogenisieren der in Schritt (i) erhaltenen Lösung, In a preferred embodiment of the invention, the preparation of solution A comprises the following steps: a) preparation of a solution B stirring at a temperature in the range between 20 ° and 100 ° C., solution B being polyethylene glycol, Glycerol, polyvinyl alcohol, at least one defoamer, sugar, at least one oily component, at least one Emu lgator and water as a solvent, ß) Preparation of a solution C by dissolving starch in water at Raumtemperatu r, γ) Einrüh ren of the solution B in solution C. In a further preferred embodiment of the invention, the preparation of solution A or the preparation of solution B comprises the following steps: i) dissolving polyethylene glycol and glycerol in boiling water, ii) homogenizing the solution obtained in step (i),
iii) Hinzufügen von Polyvinylalkohol-Granulat unter Rühren, iii) adding polyvinyl alcohol granules with stirring,
iv) Homogenisieren der in Schritt (iii) gewonnen Lösung, iv) homogenizing the solution obtained in step (iii),
v) Hinzufügen eines Entschäumers zu der Lösung, v) adding a defoamer to the solution,
vi) Hinzufügen von Zucker zu der Lösung, vi) adding sugar to the solution,
vii) Vermengen mindestens einer öligen Komponente mit mindestens einem Emulgator in einem separaten Behälter und vii) mixing at least one oily component with at least one emulsifier in a separate container and
viii) Hinzufügen des in Schritt (vii) erhaltenen Substanzgemisches zu der in den Schritten (i) bis (vi) erhaltenen Lösung. viii) adding the mixture of substances obtained in step (vii) to the solution obtained in steps (i) to (vi).
Durch ein solches Verfahren wird die Herstellung von essbaren Folien ermöglicht, die eine auch nach langer Lagerung trockene und gleichmäßige Filmoberfläche aufweisen. Such a process makes it possible to produce edible films which have a dry and uniform film surface even after long storage.
Das Homogenisieren erfolgt vorzugsweise in einem Rührkessel bei 10000 bis 20000 Umdrehungen/min, insbesondere bei 16000 Umdrehungen/min, wodurch die Qualität, insbesondere die Gleichmäßigkeit der Filmoberfläche, der essbaren Folien, die aus der Folienformulierung hergestellt werden, verbessert wird. The homogenization is preferably carried out in a stirred tank at 10,000 to 20,000 revolutions per minute, in particular at 16,000 revolutions per minute, whereby the quality, in particular the uniformity of the film surface, of the edible films which are produced from the film formulation is improved.
Vorzugsweise wird der Schritt (vii) in etwa bei Raumtemperatur durchgeführt, um die Qualität der eingesetzten öligen Komponente nicht zu beeinträchtigen. Preferably, step (vii) is performed at about room temperature so as not to affect the quality of the oily component used.
In einer bevorzugten Ausführungsform der Erfindung wird die Folienformulierung für eine essbare Folie aus In a preferred embodiment of the invention, the film formulation becomes an edible film
9 - 16 GewJ% Stärke 9 - 16 wt% starch
5 - 10 GewJ% Polyethylenglykol  5-10% by weight of polyethylene glycol
0,1 - 0,5 Gew./% Emulsionsstabilisator 10 - 15 Gew./% Polyvinylalkohol 0.1-0.5% by weight emulsion stabilizer 10 - 15% by weight polyvinyl alcohol
4 - 6 GewJ% Glycerin  4 - 6 wt% glycerol
3 - 6 Gew./% Zucker  3 - 6% by weight of sugar
0,001 - 0,2 Gew./% Entschäumer  0.001-0.2% by weight defoamer
0,1 - 0,15 Gew./% Emulgator  0.1-0.15% w / w emulsifier
7 - 10 GewJ% ölige Komponente  7-10% by weight oily component
35 - 50 Gew./% Wasser hergestellt. Als Stärke hat sich die Verwendung von Reisstärke als vorteilhaft erwiesen. Ein geeigneter Emulsionsstabilisator (bzw. Verdichtungsmittel) ist Hydroxypropylmethylcellulose (HPMC E3). Als Entschäumer und als Emulgator werden modifizierte Polydimethoxysilane eingesetzt.  35 - 50 Gew./% water produced. As a starch, the use of rice starch has proven to be advantageous. A suitable emulsion stabilizer (or compaction agent) is hydroxypropylmethylcellulose (HPMC E3). As defoamers and as emulsifier modified polydimethoxysilanes are used.
Des Weiteren wird die Aufgabe der vorliegenden Erfindung durch eine essbare Folie gelöst, wobei die essbare Folie aus einer Folienformulierung, die gemäß dem erfindungsgemäßen Herstellungsverfahren hergestellt wurde, hergestellt wird, also mindestens eine ölige Komponente enthält. Eine solche essbare Folie weist eine gleichmäßige Filmoberfläche auf und ist trocken, da die öligen Komponenten durch die Verwendung eines Emulgators und eines Entschäumers an einem Austreten oder Agglomerieren in der essbaren Folie gehindert werden. Zudem enthält eine solche essbare Folie keine oder nur sehr geringe Lufteinschlüsse, wodurch die Biegsamkeit der Folie erhöht und deren Brüchigkeit verringert wird. Nicht zuletzt wird hierdurch auch ein noch genaueres Dosieren von Inhaltsstoffen der essbaren Folie ermöglicht. Furthermore, the object of the present invention is achieved by an edible film, wherein the edible film of a film formulation, which was prepared according to the manufacturing method according to the invention, is prepared, that contains at least one oily component. Such an edible film has a uniform film surface and is dry because the oily components are prevented from leaking or agglomerating in the edible film by the use of an emulsifier and a defoamer. In addition, such an edible film contains no or very little air pockets, which increases the flexibility of the film and its brittleness is reduced. Last but not least, this also allows even more accurate dosing of ingredients of the edible film.
Die erfindungsgemäße essbare Folie wird zweckmäßigerweise in einer Dicke von ungefähr 60 m bis 100 m gefertigt. The edible film according to the invention is expediently produced in a thickness of approximately 60 m to 100 m.
Weiterhin wird die Aufgabe der vorliegenden Erfindung durch eine Verwendung der erfindungsgemäßen essbaren Folie zur oralen Applikation von bioaktiven Substanzen gelöst. Die essbare Folie wird dabei als Trägermedium für die orale Verabreichung von bioaktiven Substanzen und besonders bevorzugt von Medikamenten verwendet. Des Weiteren wird d ie Aufgabe der vorliegenden Erfindung du rch eine Verwendung der erfindungsgemäßen essbaren Folie zur Dosierung von Lebensmittelzusatzstoffen gelöst. Furthermore, the object of the present invention is achieved by a use of the edible film according to the invention for oral administration of bioactive substances. The edible film is used as a carrier medium for the oral administration of bioactive substances and more preferably of medicaments. Furthermore, the object of the present invention is achieved by using the edible film according to the invention for dosing food additives.
Es ist aber auch denkbar weitere Wirkstoffe oder Hilfsstoffe, wie beispielsweise Gesch macks- oder Farbstoffe, in d ie essbare Folie einzubringen . However, it is also conceivable to introduce further active ingredients or auxiliaries, such as, for example, paints or dyes into the edible film.
I m Folgenden wird die Erfindung anhand eines Beispiels näher besch rieben . In the following, the invention will be described in more detail by way of example.
Als Rohstoffe zur Herstellung einer Folienformulierung für eine essbare Folie werden beispielsweise d ie folgenden Rohstoffe verwendet: As raw materials for producing a film formulation for an edible film, for example, the following raw materials are used:
Der Wassergehalt der erfindungsgemäßen essbaren Folie hängt von den Trocknungsbed ingungen ab und kann variieren . Ein Herstellungsverfahren einer Folienformulierung für eine essbare Folie, in der eine oder mehrere ölige Komponenten gebunden sind und beim Herstellungs- prozess entstehende Luftblasen reduziert werden, kann zum Beispiel wie folgt ablaufen: a) 50 % der Gesamtmenge an Wasser wird erhitzt, bis die Siedetemperatur erreicht ist. The water content of the edible film according to the invention depends on the conditions of drying and may vary. For example, a production process of a film formulation for an edible film in which one or more oily components are bound and air bubbles produced in the manufacturing process are reduced may be as follows: a) 50% of the total amount of water is heated until the boiling temperature is reached is.
b) In das siedende Wasser wird die erforderliche Menge Polyethylenglykol 1000 (PEG-1000) und Glycerin hinzugegeben und aufgelöst. Danach wird die Lösung in einen Rührkessel mit Homogenisator bei 16000 U/min eingefüllt. b) In the boiling water, the required amount of polyethylene glycol 1000 (PEG-1000) and glycerol is added and dissolved. Thereafter, the solution is poured into a stirred tank with homogenizer at 16000 U / min.
c) Unter ständiger Zirkulation wird in die noch heiße Lösung die erforderliche Menge Polyvinylalkohol (Mowiol® 4-88) hinzugefügt. c) Under continuous circulation is added to the required amount of polyvinyl alcohol (in the still hot solution Mowiol ® 4-88).
d) Diesem Gemisch wird als Entschäumer, ein modifiziertes Polydimethylsilo- xan, hinzugefügt. d) This mixture is added as a defoamer, a modified polydimethylsiloxane.
e) Anschließend wird die benötigte Zuckermenge untergemischt. e) Subsequently, the required amount of sugar is mixed in.
f) Parallel wird in einem separaten Behältnis die erforderliche Menge der öligen Komponente (oder einem Gemisch aus mehrerer öliger Komponenten) mit dem Emulgator vermengt und der Lösung aus Schritt (e) hinzugefügt. f) In einem weiteren Schritt wird parallel in einem separaten Behälter die f) In parallel, the required amount of the oily component (or a mixture of several oily components) is mixed with the emulsifier in a separate container and added to the solution of step (e). f) In a further step is parallel in a separate container the
Reisstärke mit den restlichen 50 % der Gesamtmenge des Wassers bei Raumtemperatur aufgelöst.  Rice starch dissolved with the remaining 50% of the total amount of water at room temperature.
h) Die in Schritt (e) gewonnene Lösung wird in die Lösung aus Schritt (d) eingerührt. Unter Beibehaltung der Drehzahl aus Schritt (b) für den Homogenisator wird die Lösung auf eine Temperatur von 80 °C erhitzt. Bei Erreichen der gewünschten Temperatur ist die Stärke vollständig gebunden. i) Abschließend wird das Gemisch auf 50 °C heruntergekühlt. h) The solution obtained in step (e) is stirred into the solution from step (d). While maintaining the speed of step (b) for the homogenizer, the solution is heated to a temperature of 80 ° C. Upon reaching the desired temperature, the starch is completely bound. i) Finally, the mixture is cooled down to 50 ° C.
j) Abfüllen der essbaren Filmlösung, die eine oder mehrere ölige Komponenten und eine stark reduzierte Menge an Luftblasen enthält. j) filling the edible film solution containing one or more oily components and a greatly reduced amount of air bubbles.
Abschließend wird die Folienformulierung abgekühlt und zu einer essbaren Folie verarbeitet. Abhängig von der gewünschten Verwendung der Folienformulierung, kann diese zusätzlich zu den oben genannten Substanzen Arzneistoffe und/oder H ilfsstoffe, wie Gesch macksstoffe und/oder (Lebensmittel-)Farbstoffe enthalten . Finally, the film formulation is cooled and processed into an edible film. Depending on the desired use of the film formulation, it may contain, in addition to the above-mentioned substances, pharmaceutical substances and / or auxiliary substances such as flavoring agents and / or (food) dyes.

Claims

Ansprüche claims
Verfahren zu r Herstellung einer Folienformu lierung für eine essbare Folie, folgende Schritte umfassend : a) Herstellung einer Lösung A du rch Rüh ren bei einer Temperatur im Bereich zwischen 20 ° bis 1 00 °C, wobei d ie Lösung A Stärke, Polyethy- lenglykol, Glycerin , Polyvinylalkohol, mindestens einen Entschäumer, Zucker, mindestens eine ölige Komponente, mindestens einen Emu l- gator und Wasser als Lösungsmittel enthält, b) Homogen isieren und Temperieren der in Schritt (a) erhaltenen Lösung auf eine Temperatu r von mindestens 70 °C, vorzugsweise auf ca.A process for producing a film formulation for an edible film comprising the steps of: a) preparing a solution A stirring at a temperature in the range of 20 ° to 100 ° C, the solution A being starch, polyethylene glycol , Glycerin, polyvinyl alcohol, at least one defoamer, sugar, at least one oily component, at least one Emu l- gator and water as a solvent, b) homogenizing and homogenizing the temperature of the solution obtained in step (a) to a temperature of at least 70 ° C, preferably at approx.
80 °C bis 85 °C, c) Herunterkühlen der in Sch ritt (b) erhaltenen Lösung . 80 ° C to 85 ° C, c) cooling down the solution obtained in step (b).
Verfahren nach Anspruch 1 , Method according to claim 1,
dadu rch gekennzeichnet, characterized,
dass d ie Herstellung der Lösung A d ie folgenden Schritte umfasst: a) Herstellung einer Lösung B du rch Rüh ren bei einer Temperatur im Bereich zwischen 20 ° bis 1 00 °C, wobei d ie Lösung B Polyethylengly- kol, Glycerin , Polyvinylalkohol, mindestens einen Entschäu mer, Zucker, mindestens eine ölige Komponente, mindestens einen Emulga- tor und Wasser als Lösungsmittel enthält, ß) Herstellung einer Lösung C durch Lösen von Stärke in Wasser bei Raumtemperatu r, γ) Einrüh ren der Lösung B in Lösung C. that the preparation of the solution A comprises the following steps: a) preparation of a solution B stirring at a temperature in the range between 20 ° and 100 ° C., the solution B being polyethylene glycol, glycerol, polyvinyl alcohol, at least one defoamer, sugar, at least one oily component, at least one emulsifier and water as solvent, ß) Preparation of a solution C by dissolving starch in water at room temperature, γ) stirring solution B in solution C.
3. Verfahren nach einem der Ansprüche 1 oder 2, 3. The method according to any one of claims 1 or 2,
dadurch gekennzeichnet,  characterized,
dass die Herstellung der Lösung A oder die Herstellung der Lösung B die folgenden Schritte umfasst: i) Auflösen von Polyethylenglykol und Glycerin in siedendem Wasser, ii) Homogenisieren der in Schritt (i) erhaltenen Lösung,  that the preparation of solution A or the preparation of solution B comprises the following steps: i) dissolving polyethylene glycol and glycerol in boiling water, ii) homogenizing the solution obtained in step (i),
iii) Hinzufügen von Polyvinylalkohol unter Rühren,  iii) adding polyvinyl alcohol with stirring,
iv) Homogenisieren der in Schritt (iii) gewonnen Lösung,  iv) homogenizing the solution obtained in step (iii),
v) Hinzufügen eines Entschäumers zu der Lösung,  v) adding a defoamer to the solution,
vi) Hinzufügen von Zucker zu der Lösung,  vi) adding sugar to the solution,
vii) Vermengen mindestens einer öligen Komponente mit mindestens einem Emulgator in einem separaten Behälter und  vii) mixing at least one oily component with at least one emulsifier in a separate container and
viii) Hinzufügen des in Schritt (vii) erhaltenen Substanzgemisches zu der in den Schritten (i) bis (vi) erhaltenen Lösung.  viii) adding the mixture of substances obtained in step (vii) to the solution obtained in steps (i) to (vi).
4. Verfahren nach Anspruch 3, 4. The method according to claim 3,
dadurch gekennzeichnet,  characterized,
dass das Homogenisieren in einem Rührkessel bei 10000 bis 20000 Umdrehungen/min erfolgt.  the homogenization takes place in a stirred tank at 10,000 to 20,000 revolutions / min.
5. Verfahren nach Anspruch 3, 5. The method according to claim 3,
dadurch gekennzeichnet,  characterized,
dass der Schritt (vii) in etwa bei Raumtemperatur durchgeführt wird. that step (vii) is carried out at about room temperature.
6. Verfahren nach einem der vorangestellten Ansprüche, 6. Method according to one of the preceding claims,
dadurch gekennzeichnet,  characterized,
dass die essbare Folienformulierung aus  that the edible film formulation of
9 - 16 Gew./% Stärke 9 - 16% by weight
5 - 10 Gew./% Polyethylenglykol  5 to 10% by weight of polyethylene glycol
0,1 - 0,5 Gew./% Emulsionsstabilisator  0.1-0.5% by weight emulsion stabilizer
10 - 15 Gew./% Polyvinylalkohol  10 - 15% by weight polyvinyl alcohol
4 - 6 Gew./% Glycerin  4 - 6% by weight of glycerol
3 - 6 GewJ% Zucker  3 - 6% by weight of sugar
0,001 - 0,2 Gew./% Entschäumer  0.001-0.2% by weight defoamer
0,1 - 0,15 Gew./% Emulgator  0.1-0.15% w / w emulsifier
7 - 10 Gew./% ölige Komponente  7-10% by weight oily component
35 - 50 GewJ% Wasser hergestellt wird.  35-50% by weight of water is produced.
7. Essbare Folie, hergestellt aus einer Folienformulierung, die mit einem Verfahren nach mindestens einem der vorangestellten Ansprüche erhalten wurde. An edible film made from a film formulation obtained by a process according to any one of the preceding claims.
Verwendung der essbaren Folie nach Anspruch 7 zur oralen Applikation von bioaktiven Substanzen. Use of the edible film according to claim 7 for the oral administration of bioactive substances.
Verwendung der essbaren Folie nach Anspruch 8, Use of the edible film according to claim 8,
dadurch gekennzeichnet,  characterized,
dass die bioaktive Substanz ein Medikament ist.  that the bioactive substance is a drug.
Verwendung der essbaren Folien nach Anspruch 7 zur Dosierung von Lebensmittelzusatzstoffen. Use of the edible films according to claim 7 for the dosing of food additives.
EP12733056.1A 2012-06-28 2012-06-28 Method for producing a film formulation for an edible film, and the use thereof Active EP2866592B1 (en)

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US6596298B2 (en) * 1998-09-25 2003-07-22 Warner-Lambert Company Fast dissolving orally comsumable films
US6962715B2 (en) 2001-10-24 2005-11-08 Hewlett-Packard Development Company, L.P. Method and dosage form for dispensing a bioactive substance
NZ522071A (en) * 2002-10-18 2005-07-29 Patrick Joseph Silcock Hydrolysed casein phosphoprotein preparations for bioactive metal ion delivery and teeth remineralisation
WO2004045537A2 (en) 2002-11-14 2004-06-03 Zengen, Inc. Edible film for relief of cough or symptoms associated with pharyngitis
US8999372B2 (en) * 2002-11-14 2015-04-07 Cure Pharmaceutical Corporation Methods for modulating dissolution, bioavailability, bioequivalence and drug delivery profile of thin film drug delivery systems, controlled-release thin film dosage formats, and methods for their manufacture and use
KR100905027B1 (en) * 2007-10-03 2009-06-30 (주)씨엘팜 Edible Film
WO2009045022A2 (en) * 2007-10-03 2009-04-09 C.L. Pharm Edible film
DE102010009071A1 (en) * 2010-02-23 2011-10-06 Optimags Dr. Zimmermann Gmbh Preparing edible film useful for oral bioactivator, involves dissolving polyethylene glycol and sugar in water, and adding and mixing glycerol with polyethylene glycol-sugar solution

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